FDA Approves Channel Medsystems’ Women’s Health Cryotherapy Device
Channel Medsystems, a company dedicated to bringing innovation to the delivery of women’s healthcare, today announced that the U.S. Food and Drug Administration (FDA) recently approved the newest Cerene Cryotherapy Device, a next-generation technology for the treatment of heavy menstrual bleeding in the office setting.
Originally approved by the FDA in March 2019, Channel’s Cerene Device uses proprietary, hand-held technology to deliver cryotherapy to the lining of the uterus, freezing the tissue and significantly reducing future menstrual bleeding.
In most patients, the procedure preserves the ability to access and evaluate the uterine cavity in order to diagnose and care for intrauterine conditions post-treatment. The Cerene Device’s innovative and disposable design does not require gynecologists to invest in capital equipment, and does not require use of general anesthesia, together enabling procedures to be performed conveniently and comfortably in a gynecologist’s office. In contrast, heat-based global endometrial ablation devices currently on the market require investment in capital equipment and are typically performed with general anesthesia in hospitals or surgery centers.
Channel’s newest Cerene device delivers the same 2.5-minute cryotherapy treatment and clinically-validated effectiveness as its previously FDA-approved predecessor, further enhanced with improvements to rapidly scale-up manufacturing to meet the anticipated demand for office-based therapy. The approval comes following a comprehensive FDA review of all design and manufacturing process changes.
“We are extremely pleased to announce the latest milestone in the evolution of our Cerene technology and feel the FDA’s approval of the newest Cerene device could not be more timely,” said Ric Cote, Chief Executive Officer of Channel Medsystems. “With the COVID-19 pandemic, comfortable and efficient in-office treatment options are more critical to patients and gynecologists than ever. This approval will allow Channel, through our contract manufacturing partner SMC Ltd., to more quickly scale up and meet the demands of the marketplace. More importantly, it will put an innovative, safe and effective product for treating heavy menstrual bleeding in the hands of even more physicians, and will provide patients with the opportunity to receive effective treatment in a safe, familiar environment – their physician’s office.”
See Full Press Release at the Source: Channel Medsystems® Receives FDA Approval of its Latest Cerene® Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding in the Office Setting
Press Release by: Channel Medsystems
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